Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S. Aureus

Development of a Probiotic Strategy to Prevent or Eliminate Nasal Colonization With S Aureus

The goal of this study is characterize the changes in bacterial diversity of the nares of hemodialysis patients. Another goal is to determine when hemodialysis patients become colonized with the bacteria Staphylococcus aureus, as nasal colonization with S. aureus is a major risk factor for invasive infection in hemodialysis patients. Fifteen subjects will be recruited into the study. Nasal swabs will be collected every month for six months or until one month after S. aureus colonization in order to determine any changes in the bacterial communities of the nose. Clinical data will also be collected to evaluate the possible influence of external factors on changes in the microbial communities in the patients' noses. This study will provide preliminary data on whether oral- and/or nasal-administered probiotics can eliminate nasal carriage of S. aureus.

Study Overview

• Status: Withdrawn
• Conditions: Hemodialysis
• Intervention / Treatment: Procedure: Nasal Swab

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Boston Dialysis Center Inc outpatient hemodialysis clinic of Tufts Medical Center.

Description

Inclusion Criteria:

• Male and female subjects aged 18 years or older
• On a stable hemodialysis schedule three times a week at Tufts Medical Center outpatient hemodialysis unit
• Able to speak English, Spanish, Cantonese, or Mandarin (One of these languages is spoken by >95% of our hemodialysis population)
• Provides informed consent to participate in the study
• No plans to be absent from the dialysis unit in the next 6 months
• Willingness to report on adverse events during the study period

Exclusion Criteria:

• Patients in which hemodialysis was indicated for acute renal failure secondary to septic shock, acute tubular necrosis, or other condition which is felt to be temporary or secondary to a life threatening illness or likelihood of hemodialysis for less than 6 months.
• Treatment with systemic anti-staphylococcal antibiotic therapy within 30 days prior to enrollment or planned use of topical mupirocin applied to the nares
• Receiving peritoneal dialysis (concordance between the colonizing and infecting strain is not as high as in the hemodialysis population (105))
• Absolute neutrophil count less than 500/mm3 or anticipated fall in neutrophil count < 500/mm3 (e.g. as a result of recent chemotherapy)
• Bleeding diathesis such as platelets count less than 20 or INR >4 within the last 30 days
• On immunosuppressive therapy
• Anticipated renal transplant during the next 6 months
• Evidence of active bowel leak, acute abdomen or colitis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nasal Swab; New chronic hemodialysis patients with no evidence of nasal carriage of Staphylococcus aureus from Boston Dialysis Center Inc., the outpatient hemodialysis clinic of Tufts Medical Center	Procedure: Nasal Swab; Swabs will be moistened in sterile 0.9% sodium chloride solution and rotated in the anterior vestibule of both nares and processed for S aureus cultures and for bacterial DNA extraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To describe the clinical variables that may be associated with the acquisition of S aureus nasal colonization, over a six-month period.	Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus
To refine and test the feasibility of using non culture-based methods to study the microbial ecology and bacterial diversity of the anterior nares in patients starting hemodialysis using 16sRNA sequence analysis.	Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus
To explore changes in bacterial diversity in the anterior nares over a six-month period and in conjunction with S aureus colonization.	Monthly for 6 months or monthly until 1 month after positive nasal swab for S aureus

Collaborators and Investigators

• Sponsor: Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; hemodialysis; microbiota
• Other Study ID Numbers: 8784 (CTEP)